510(k) · Cleared
ClearedSurgisis Staple Line Reinforcement II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech, Inc. · FTM Mesh, Surgical
Cleared on Sep 23, 2005 as substantially equivalent to K022044 (Cook Biotech, Inc., 2002) and 3 other predicates after a 151-day review. Its family tree reaches back 8 generations to 1985. 3 later devices descend from it.
- Decided
- Sep 23, 2005
- Review
- 151 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K842066 (1985). 28 ancestors in all, the oldest K830889 (1983). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 7 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 5 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 4 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 3 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 1 generation backK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
- This deviceK051048 Surgisis Staple Line Reinforcement IICook Biotech, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK070405 Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK170945 Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2017
- Descendant · 3 generations on · 0 of its ownK201000 Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2020
Most influential descendants
Showing 3 of 3 · See all- K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc. · 2007 · cites it directly2descendants
- K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2017 · 2 generations on1descendant
- K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −7 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −5 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −4 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −3 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −1 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
| 0 (this device) | K051048 | Surgisis Staple Line Reinforcement II | Cook Biotech, Inc. | 2005 | — |
| +1 | K070405 | Modification to Surgisis SLR Staple Line Reinforcement | Cook Biotech, Inc. | 2007 | — |
| +2 | K170945 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2017 | — |
| +3 | K201000 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022044 | Surgisis Staple Line ReinforcementSummary page 1…intended for one-time use. Predicate Devices: SURGISIS® Staple Line Reinforcement LI is similar to predicate devices, including the SURGIsIS® Staple Line Reinforcement (K022044) and SURGISIS® Soft Tissue Graft (K98043 1) manufactured by Cook Biotech Incorporated, Peri-Strips ® Staple Line Reinforcement (K… | 2002 |
| * | K980431 | SurgisisSummary page 1…ces: SURGISIS® Staple Line Reinforcement LI is similar to predicate devices, including the SURGIsIS® Staple Line Reinforcement (K022044) and SURGISIS® Soft Tissue Graft (K98043 1) manufactured by Cook Biotech Incorporated, Peri-Strips ® Staple Line Reinforcement (K040119) manufactured by Synovis Surgical In… | 1998 |
| * | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Summary page 1…GIsIS® Staple Line Reinforcement (K022044) and SURGISIS® Soft Tissue Graft (K98043 1) manufactured by Cook Biotech Incorporated, Peri-Strips ® Staple Line Reinforcement (K040119) manufactured by Synovis Surgical Innovations, and Gore Seamguard® Bioabsorbable Staple Line Reinforcement Material (K032865) man… | 2004 |
| * | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialSummary page 1…ed, Peri-Strips ® Staple Line Reinforcement (K040119) manufactured by Synovis Surgical Innovations, and Gore Seamguard® Bioabsorbable Staple Line Reinforcement Material (K032865) manufactured by W.L. Gore & Associates. Device Description: SURGISIS® Staple Line Reinforcement II is manufactured from porcine… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070405 | Modification to Surgisis SLR Staple Line Reinforcement | 2007 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K070405 (Cook Biotech, Inc., 2007) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K022044.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
SURGISlS® Staple Line Reinforcement Il is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomylpneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be…
Read the full statement (118 words)
SURGISlS® Staple Line Reinforcement Il is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomylpneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon, and colorectal procedures. The device may be used with anastomotic staplers or non-anastomnotic staplers. The device is supplied sterile and is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051048: Surgisis Staple Line Reinforcement II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051048
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026